COZAAR COMP 100MG/ 25MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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S1629 LEAFLET Cozaar comp 20140829



if you have high calcium or low potassium levels or you are on a
low potassium diet



if you need to have an anaesthetic (even at the dentist) or
before surgery, or if you are going to have tests to check your
parathyroid function, you must tell the doctor or medical staff
that you are taking losartan potassium and hydrochlorothiazide
tablets



if you suffer from primary hyperaldosteronism (a syndrome
associated with increased secretion of the hormone aldosterone
by the adrenal gland, caused by an abnormality within the
gland).



if you are taking a medicine called aliskiren to reduce blood
pressure.

PACKAGE LEAFLET: INFORMATION FOR THE USER

COZAAR® COMP 100mg/25mg
FILM‑COATED TABLETS
(losartan potassium and hydrochlorothiazide)
The name of your medicine is Cozaar Comp 100mg/ 25mg
Film‑coated Tablets but will be referred to as Cozaar Comp
throughout the following leaflet.
Please note that information regarding other strengths of Cozaar
Comp Tablets (50mg/ 12.5mg & 100mg/25mg) may also be present
in the below leaflet.
Read all of this leaflet carefully before taking this medicine
because it contains important information for you.


Keep this leaflet. You may need to read it again.

Children and adolescents



If you have any further questions, ask your doctor, pharmacist
or nurse.

There is no experience with the use of Cozaar Comp in children.
Therefore, Cozaar Comp should not be given to children.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.

Other medicines and Cozaar Comp



If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1. What Cozaar Comp is and what it is used for
2. What you need to know before you take Cozaar Comp
3. How to take Cozaar Comp
4. Possible side effects
5. How to store Cozaar Comp
6. Contents of the pack and other information
1. WHAT COZAAR COMP IS AND WHAT IT IS USED FOR
Cozaar Comp is a combination of an angiotensin II receptor
antagonist (losartan) and a diuretic (hydrochlorothiazide).
Angiotensin II is a substance produced in the body which binds to
receptors in blood vessels, causing them to tighten. This results in
an increase in blood pressure. Losartan prevents the binding of
angiotensin II to these receptors, causing the blood vessels to relax
which in turn lowers the blood pressure. Hydrochlorothiazide works
by making the kidneys pass more water and salt. This also helps to
reduce blood pressure.
Cozaar Comp is indicated for the treatment of essential
hypertension (high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COZAAR
COMP
Do not take Cozaar Comp

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Diuretic agents such as the hydrochlorothiazide contained in
Cozaar Comp may interact with other medicines.
Preparations containing lithium should not be taken with Cozaar
Comp without close supervision by your doctor.
Special precautionary measures (e.g. blood tests) may be
appropriate if you take potassium supplements,
potassium‑containing salt substitutes or potassium‑sparing
medicines, other diuretics (“water tablets”), some laxatives,
medicines for the treatment of gout, medicines to control heart
rhythm or for diabetes (oral agents or insulins).
It is also important for your doctor to know if you are taking
• other medicines to reduce your blood pressure
• steroids
• medicines to treat cancer
• pain killers
• drugs for treatment of fungal infections
• arthritis medicines
• resins used for high cholesterol, such as cholestyramine
• medicines which relax your muscles
• sleeping tablets
• opioid medicines such as morphine
• ‘pressor amines’ such as adrenaline or other drugs from the
same group
• oral agents for diabetes or insulins.
Please also inform your doctor if you are taking Cozaar Comp and
you will be undergoing a radiographic procedure and will be given
iodine contrast media.



if you are allergic to losartan, hydrochlorothiazide or to any of
the other ingredients of this medicine (listed in section 6)



Cozaar Comp with food and drink

if you are allergic to other sulfonamide‑derived substances (e.g.
other thiazides, some antibacterial drugs such as
co‑trimoxazole, ask your doctor if you are not sure)

You are advised not to drink alcohol whilst taking these tablets:
alcohol and Cozaar Comp tablets may increase each other’s
effects.



if you have severely impaired liver function



if you have low potassium, low sodium or high calcium levels
which cannot be corrected by treatment

Dietary salt in excessive quantities may counteract the effect of
Cozaar Comp tablets.



if you are suffering from gout



if you are more than 3 months pregnant. (It is also better to
avoid Cozaar Comp in early pregnancy - see Pregnancy
section)



if you have severely impaired kidney function or your kidneys
are not producing any urine,



if you have diabetes or impaired kidney function and are taking
a medicine called aliskiren to reduce blood pressure.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Cozaar
Comp.
You must tell your doctor if you think you are (or might become)
pregnant. Cozaar Comp is not recommended in early pregnancy,
and must not be taken if you are more than 3 months pregnant, as it
may cause serious harm to your baby if used at that stage
(see pregnancy section).
It is important to tell your doctor before taking Cozaar Comp:

Cozaar Comp tablets may be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Cozaar Comp before you become pregnant or as soon as you know
you are pregnant and will advise you to take another medicine
instead of Cozaar Comp. Cozaar Comp is not recommended during
pregnancy, and must not be taken when more than 3 months
pregnant, as it may cause serious harm to your baby if used after
the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Cozaar Comp is not recommended for mothers who are
breast-feeding, and your doctor may choose another treatment for
you if you wish to breast-feed.
Use in elderly patients



if you have previously suffered from swelling of the face, lips,
throat or tongue



Cozaar Comp works equally well in and is equally well tolerated by
most older and younger adult patients. Most older patients require
the same dose as younger patients.

if you take diuretics (water pills)

Driving and using machines



if you are on a salt‑restricted diet



if you have or have had severe vomiting and/or diarrhoea

When you begin treatment with this medication, you should not
perform tasks which may require special attention (for example,
driving an automobile or operating dangerous machinery) until you
know how you tolerate your medicine.



if you have heart failure



if your liver function is impaired (see section 2 “Do not take
Cozaar Comp”)



if you have narrow arteries to your kidneys (renal artery
stenosis) or only have one functioning kidney, or you have
recently had a kidney transplant



if you have narrowing of the arteries (atherosclerosis), angina
pectoris (chest pain due to poor heart function)



if you have ‘aortic or mitral valve stenosis’ (narrowing of the
valves of the heart) or ‘hypertrophic cardiomyopathy’ (a disease
causing thickening of heart muscle)



if you are diabetic



if you have had gout



if you have or have had an allergic condition, asthma or a
condition that causes joint pain, skin rashes and fever (systemic
lupus erythematosus)

Cozaar Comp contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product.
3. HOW TO TAKE COZAAR COMP
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide on the appropriate dose of Cozaar Comp
depending on your condition and whether you are taking other
medicines. It is important to continue taking Cozaar Comp for as
long as your doctor prescribes it in order to maintain smooth control
of your blood pressure.

High Blood Pressure
The usual dose of Cozaar Comp for most patients with high blood
pressure is 1 tablet of Cozaar Comp 50 mg/12.5 mg per day to
control blood pressure over the 24‑hour period. This can be
increased to 2 tablets once daily of Losartan / Hydrochlorothiazide
50 mg/12.5 mg Film‑Coated Tablets or changed to 1 tablet daily of
Losartan / Hydrochlorothiazide 100 mg/25 mg Film‑Coated Tablets
(a stronger strength) per day. The maximum daily dose is 2 tablets
per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg
Film‑Coated Tablets or 1 tablet daily of Losartan /
Hydrochlorothiazide 100 mg/25 mg Film‑Coated Tablets

Rare (may affect up to 1 in 1,000 people):


Hepatitis (inflammation of the liver), abnormal liver function
tests

Not known (frequency cannot be estimated from the available data):


Flu-like symptoms



Unexplained muscle pain with dark (tea-colored) urine
(rhabdomyolysis)



Low levels of sodium in the blood (hyponatraemia)



Generally feeling unwell (malaise)

Reporting of side effects
If you take more Cozaar Comp than you should
In case of an overdose, contact your doctor immediately so that
medical attention may be given promptly. Overdose can cause a
drop in blood pressure, palpitations, slow pulse, changes in blood
composition, and dehydration.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any side effects not listed in this leaflet. You can also
report side effects directly (see details below). By reporting side
effects you can help provide more information on the safety of this
medicine.

If you forget to take Cozaar Comp

United Kingdom: Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard

Try to take Cozaar Comp daily as prescribed. However, if you miss
a dose, do not take an extra dose. Just resume your usual
schedule.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Ireland: Pharmacovigilance Section, Irish Medicines Board, Kevin
O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL - Dublin 2,
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.imb.ie,
e-mail: imbpharmacovigilance@imb.ie
Malta: ADR Reporting, The Medicines Authority, Post-Licensing
Directorate, 203 Level 3, Rue D’Argens, GŻR-1368 Gżira Website:
www.medicinesauthority.gov.mt, e-mail:
postlicensing.medicinesauthority@gov.mt

If you experience the following, stop taking Cozaar Comp tablets
and tell your doctor immediately or go to the casualty department of
your nearest hospital:

5. HOW TO STORE COZAAR COMP

A severe allergic reaction (rash, itching, swelling of the face, lips,
mouth or throat that may cause difficulty in swallowing or
breathing).



Do not store above 30°C.



Store in the original package to protect from light and moisture.



Do not open the blister pack until you are ready to take the
medicine.



Do not use the Cozaar Comp after the expiry date (EXP) stated
on the packaging. The term validity refers to the last day of the
month.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

This is a serious but rare side effect, which affects more than 1 out
of 10,000 patients but fewer than 1 out of 1,000 patients. You may
need urgent medical attention or hospitalisation.
The following side effects have been reported:



Common (may affect up to 1 in 10 people):


Cough, upper airway infection, congestion in the nose, sinusitis,
sinus disorder



Diarrhoea, abdominal pain, nausea, indigestion



Muscle pain or cramps, leg pain, back pain



Insomnia, headache, dizziness



Weakness, tiredness, chest pain



Increased potassium levels (which can cause an abnormal
heart rhythm), decreased haemoglobin levels



Changes in kidney function including kidney failure



Too low sugar in the blood (hypoglycaemia)

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cozaar Comp contains


Cozaar Comp 100mg/ 25mg contains 100 mg of losartan
potassium and 25 mg of hydrochlorothiazide as the active
ingredients.



The other ingredients are: microcrystalline cellulose, lactose
monohydrate, pregelatinised maize starch, magnesium
stearate, hydroxypropyl cellulose, hypromellose, titanium
dioxide (E171), quinoline yellow aluminum lake (E104) and
carnauba wax (E903).

Uncommon (may affect up to 1 in 100 people):


Anaemia, red or brownish spots on the skin (sometimes
especially on thefeet, legs, arms and buttocks, with joint pain,
swelling of the hands and feet and stomach pain), bruising,
reduction in white blood cells, clotting problems, reduced
number of platelets



Loss of appetite, increased uric acid levels or frank gout,
increased blood sugar levels, abnormal blood electrolyte levels



Anxiety, nervousness, panic disorder (recurring panic attacks),
confusion, depression, abnormal dreams, sleep disorders,
sleepiness, memory impairment



Pins and needles or similar sensations, pain in the extremities,
trembling, migraine, fainting



Blurred vision, burning or stinging in the eyes, conjunctivitis,
worsening eyesight, seeing things in yellow



Ringing, buzzing, roaring or clicking in the ears, vertigo



Low blood pressure, which may be associated with changes in
posture (feeling light-headed or weak when you stand up,
angina (chest pain), abnormal heartbeat, cerebrovascular
accident (TIA, “mini-stroke”), heart attack, palpitations

Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of
potassium.
What Cozaar Comp looks like and contents of the pack


Cozaar Comp 100mg/ 25mg is available as light yellow, oval
film-coated tablets marked 747 on one side and plain on the
other.



Cozaar Comp is available as blister packs containing 28 tablets.

Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Merck Sharp & Dohme BV,
Waardeweg 39, 2031 BN Haarlem, The Netherlands.



Inflammation of blood vessels, which is often associated with a
skin rash or bruising



Sore throat, breathlessness, bronchitis, pneumonia, water on
the lungs (which causes difficulty breathing), nosebleed, runny
nose, congestion

Leaflet revision date: 29 August 2014



Constipation, obstipation, wind, stomach upsets, stomach
spasms, vomiting, dry mouth, inflammation of a salivary gland,
toothache

Cozaar is a registered trade mark of EI du Pont de Nemours &
Company, USA.



Jaundice (yellowing of the eyes and skin), inflammation of the
pancreas



Hives, itching, inflammation of the skin, rash, redness of the
skin, sensitivity to light, dry skin, flushing, sweating, hair loss



Pain in the arms, shoulders, hips, knees or other joints, joint
swelling, stiffness, muscle weakness



Frequent urination including at night, abnormal kidney function
including inflammation of the kidneys, urinary tract infection,
sugar in the urine



Decreased sexual appetite, impotence



Swelling of the face, localised swelling (oedema), fever

POM

PL No. 19488/1629

S1629 LEAFLET Cozaar comp 20140829

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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